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Trial registered on ANZCTR


Registration number
ACTRN12619000184178p
Ethics application status
Submitted, not yet approved
Date submitted
2/02/2019
Date registered
8/02/2019
Date last updated
8/02/2019
Date data sharing statement initially provided
8/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Immunogenicity of oral polio vaccine in different doses in Mozambique
Scientific title
Comparison of Immunogenicity of mOPV2 administered as 1-drop or 2-drop oral dose to infants in Mocuba district, Mozambique, 2019
Secondary ID [1] 297279 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
poliomyelitis 311357 0
Condition category
Condition code
Infection 309993 309993 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study arm A: one drop (reduced dose=0.05 mL) of monovalent oral poliovirus vaccine type 2 (mOPV2), containing half of 10^5 +/- 0.5 log TCID 50 (50% Tissue culture Infective Dose) of type 2 Sabin virus
Intervention code [1] 313531 0
Treatment: Drugs
Intervention code [2] 313580 0
Prevention
Comparator / control treatment
Study arm B: two drops (normal dose=0.1 mL) of monovalent oral poliovirus vaccine type 2 (mOPV2) containing 10^5 +/- 0.5 log TCID 50 (50% Tissue culture Infective Dose) of type 2 Sabin virus
Control group
Dose comparison

Outcomes
Primary outcome [1] 318904 0
Seroconversion after one full or reduced dose of mOPV2 expressed by increase in poliovirus type 2 antibodies assessed by neutralization assay test of sera
Timepoint [1] 318904 0
Comparison of proportion of children who seroconverted 14 days after one or two drops of mOPV2 vaccine
Secondary outcome [1] 366373 0
Titre of poliovirus type 2 neutralizing antibodies after one or two drops of mOPV2 assessed by neutralization assay test of sera
Timepoint [1] 366373 0
14 days after intervention

Eligibility
Key inclusion criteria
healthy child between 9-22 months of age living in study area
Minimum age
9 Months
Maximum age
22 Months
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
no consent
residence outside of study area
known immunodeficiency

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21242 0
Mozambique
State/province [1] 21242 0

Funding & Sponsors
Funding source category [1] 301837 0
Other
Name [1] 301837 0
World Health Organization
Address [1] 301837 0
20 Appia Avenue, 1211 Geneva
Country [1] 301837 0
Switzerland
Primary sponsor type
Other
Name
WHO
Address
20 Appia Avenue, 1211 Geneva
Country
Switzerland
Secondary sponsor category [1] 301581 0
None
Name [1] 301581 0
Address [1] 301581 0
Country [1] 301581 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 302538 0
WHO Ethics Review Committee
Ethics committee address [1] 302538 0
20 Appia Avenue, 1211 Geneva
Ethics committee country [1] 302538 0
Switzerland
Date submitted for ethics approval [1] 302538 0
12/12/2018
Approval date [1] 302538 0
Ethics approval number [1] 302538 0

Summary
Brief summary
The attenuated poliovirus strains contained in oral polio vaccine (OPV) can re-acquire the neurovirulence and transmissibility of wild poliovirus in populations with low immunity. Because of the significant burden in paralytic cases caused by outbreaks of circulating vaccine-derived poliovirus (cVDPV), it was decided to switch from trivalent to bivalent OPV containing only type 1 and 3 polioviruses, and incorporate a dose of inactivated poliovirus vaccine (IPV) in routine immunization schedules. Type 2 monovalent OPV (mOPV2) was reserved for use in response to potential VDPV2 outbreaks after the tOPV-bOPV switch in April 2016. Unfortunately, the number and size of VDPV2 outbreaks observed after the switch has exceeded expectations and the mOPV2 available in the stockpile may be insufficient.
A potential solution to stretch the mOPV2 stockpile would be giving 1 drop instead of the conventional 2 drops. The recommended content of Sabin poliovirus in a 2-drop dose of mOPV2 is at least 105 TCID50, but most batches include 2-4 times the minimum recommended amount. Therefore, half the dose of mOPV2 (i.e. 1 drop) could still induce appropriate immunogenicity. However, policy makers need clinical trials among children naïve to type 2 OPV before recommending a reduction in mOPV2 dose and trials can only be done in countries where mOPV2 can be legally used, which is those experiencing a VDPV2 outbreak, such as Mozambique.

We will conduct a clinical trial in Mocuba district, Zambezia, Mozambique that will compare the immunogenicity against type 2 poliovirus of one drop versus two drops of mOPV2. The results of this study will guide the Global Polio Eradication to develop strategies that prevent a devastating shortage in mOPV2.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90570 0
Dr Nilsa de Deus
Address 90570 0
Department of Research
Instituto Nacional de Saude (INS), Mozambique
Vila de Marracuene
Estrada Nacional N°1, Parcela N°3943
Província de Maputo
Country 90570 0
Mozambique
Phone 90570 0
+258 21430814
Fax 90570 0
Email 90570 0
ndeus1@yahoo.com
Contact person for public queries
Name 90571 0
Dr Ondrej Mach
Address 90571 0
World Health Organization
20 Appia Avenue, 1211 Geneva
Country 90571 0
Switzerland
Phone 90571 0
+41227911863
Fax 90571 0
Email 90571 0
macho@who.int
Contact person for scientific queries
Name 90572 0
Dr Ondrej Mach
Address 90572 0
World Health Organization
20 Appia Avenue, 1211 Geneva
Country 90572 0
Switzerland
Phone 90572 0
+41227911863
Fax 90572 0
Email 90572 0
macho@who.int

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
Informed consent form
Summary results
No Results